阿哌沙班获准用于预防髋/膝关节术后DVT和肺栓塞

口服抗凝剂阿哌沙班已获准用于接受髋或膝关节置换手术后患者预防深静脉血栓(DVT)，DVT可能进一步导致肺栓塞(PE)。

百时美-施贵宝(BMS)公司在3月14日的声明中说，对阿哌沙班的核准是基于在11,000余例随机分配到阿哌沙班或依诺肝素患者中进行的三项研究的结果。阿哌沙班由BMS与辉瑞公司联合开发和销售。

ADVANCE-1、ADVANCE-2和 ADVANCE-3研究在11,569例接受髋或膝关节置换手术的患者中对阿哌沙班（术后开始每日2次，每次2.5 mg）和依诺肝素（术前开始，皮下注射每日1次，每日30 mg或 40 mg）进行了比较。

阿哌沙班的商品名为艾乐妥，是一种选择性因子Xa抑制剂，于2012年通过核准，用于非瓣膜性心房纤颤患者降低卒中和全身性栓塞风险，推荐剂量为5 mg，每日2次。对新的适应证的推荐剂量为2.5 mg，每日2次。

阿哌沙班处方信息中包含一项关于增加脊髓或硬膜外血肿风险的加框警告，“这可能导致”接受脊髓硬膜外麻醉或脊髓穿刺并同时采用阿哌沙班治疗的患者发生“长期或永久性麻痹”。

BMS声称，目前美国食品药品管理局(FDA)正在对一项核准阿哌沙班用于治疗深静脉血栓和肺栓塞以及降低复发性DVT和PE风险的申请进行审查。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

The oral anticoagulant apixaban has been approved for prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery.

Approval was based on the results of three studies in more than 11,000 patients randomized to apixaban or enoxaparin, according to a March 14 statement issued by Bristol-Myers Squibb, which is developing and commercializing apixaban with Pfizer.

The studies, the ADVANCE-1, ADVANCE-2, and ADVANCE-3 studies, compared apixaban (2.5 mg twice a day starting after surgery) to enoxaparin (30 mg or 40 mg administered subcutaneously once a day starting before surgery) in 11,569 patients undergoing hip or knee replacement surgery.

Apixaban, marketed as Eliquis, is a selective Factor Xa inhibitor, approved in 2012 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, at a recommended dose of 5 mg twice a day. The recommended dose for the new indication is 2.5 mg twice a day.

The apixaban prescribing information includes a boxed warning about the increased risk of spinal or epidural hematoma, "which may cause long-term or permanent paralysis" in patients treated with apixaban who are undergoing spinal epidural anesthesia or spinal puncture.

An application for approval of apixaban for the treatment of deep vein thrombosis and pulmonary embolism, and for the reduction in the risk of recurrent DVT and PE, is currently being reviewed at the Food and Drug Administration, according to BMS.